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Hyperpolarized MRI for Brain Tumor

Phase 1

Recruiting

Led By Susan Chang, MD

Research Sponsored by Susan Chang

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must be > 18 years old and with a life expectancy > 12 weeks.

Patients must have a Karnofsky performance status of ≥ 60.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 months

Awards & highlights

Study Summary

This trial is testing the side effects of a new MRI that may help diagnose glioma.

Who is the study for?

This trial is for adults over 18 with a life expectancy of more than 12 weeks and diagnosed with glioma, who are not HIV-positive, pregnant or breastfeeding. Participants must have adequate kidney function, no severe heart failure or recent heart attacks, and no other cancers except certain skin cancers or cervical carcinoma in-situ unless in remission for at least 3 years.Check my eligibility

What is being tested?

The trial tests the safety of using hyperpolarized carbon C 13 pyruvate MRI to diagnose gliomas. It involves patients already scheduled for standard treatment with radiation and temozolomide (Cohort 2), as well as those with evaluable disease based on prior MR scans (Cohort 1).See study design

What are the potential side effects?

While specific side effects are not listed, the study aims to identify any associated with hyperpolarized carbon C 13 pyruvate MRI. Potential risks may be related to the imaging process itself or reactions to the substance used.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am over 18 years old and expected to live more than 12 weeks.

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I am mostly able to care for myself but may need occasional help.

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I haven't had a heart attack or unstable chest pain in the last year.

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I have no cancer history except for non-melanoma skin cancer or cervical carcinoma in-situ, or I've been cancer-free and off treatment for 3 years.

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My heart functions well enough not to limit my physical activity.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of adverse events

Peak lactate/pyruvate ratio in (13C) pyruvate scan

Peak lactate/pyruvate ratio in brain tissue

Trial Design

2Treatment groups

Experimental Treatment

Group I: Cohort II (Hyperpolarized C13, MRI)Experimental Treatment4 Interventions

Participants receive hyperpolarized carbon C 13 pyruvate IV and undergo MRI before treatment and 4 weeks after completion of cancer therapy given outside of this study.

Group II: Cohort I (Hyperpolarized C13, MRI)Experimental Treatment2 Interventions

Participants receive hyperpolarized carbon C 13 pyruvate intravenously IV and undergo MRI. The second hyperpolarized 13 C injection/imaging will be started approximately 15 to 60 minutes after the first injection for those who are willing to receive two 13 C injections

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Chemotherapy

2003

Completed Phase 4

~3050

Hyperpolarized Carbon C 13 Pyruvate

2018

Completed Phase 1

~10

Magnetic Resonance Imaging

2017

Completed Phase 3

~1190

Radiation Therapy

2017

Completed Phase 3

~7250

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Susan ChangLead Sponsor

4 Previous Clinical Trials

377 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,664 Previous Clinical Trials

40,925,993 Total Patients Enrolled

Susan Chang, MD5.02 ReviewsPrincipal Investigator - University of California, San Francisco

University of California, San Francisco

6 Previous Clinical Trials

146 Total Patients Enrolled

Media Library

Magnetic Resonance Imaging Clinical Trial Eligibility Overview. Trial Name: NCT03739411 — Phase 1

Brain Tumor Research Study Groups: Cohort I (Hyperpolarized C13, MRI), Cohort II (Hyperpolarized C13, MRI)

Brain Tumor Clinical Trial 2023: Magnetic Resonance Imaging Highlights & Side Effects. Trial Name: NCT03739411 — Phase 1

Magnetic Resonance Imaging 2023 Treatment Timeline for Medical Study. Trial Name: NCT03739411 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment for this medical trial still open?

"According to clinicaltrials.gov, this investigation is currently enrolling volunteers and has been open since December 9th 2015 with its most recent update being on the 29th of September 2020."

Answered by AI

Has Radiation Therapy been given the green light by the FDA?

"Due to the limited evidence available, radiation therapy was assigned a safety rating of 1 on our scale from one to three. This is because this trial falls under Phase One and therefore has minimal data backing its effectiveness and security."

Answered by AI

Could you please describe the findings of preceding studies concerning Radiation Therapy?

"Presently, there are 206 active trials investigating the application of Radiation Therapy with 23 being in Phase 3. While a bulk of these experiments are based in Seoul and Songpa, 4752 other medical centres around the world have studies related to this therapy underway."

Answered by AI

In what maladies have Radiation Therapy treatments proven most efficacious?

"Radiation Therapy is typically used to reduce the effects of nitrosourea. It can also be employed for refractory directives, advanced mycosis fungoides, and in certain cases of refractory neuroblastoma."

Answered by AI

How many individuals are being recruited for this research project?

"Affirmative. Clinicaltrials.gov states that the clinical trial posted on December 9th 2015 is currently recruiting participants - 140 in total at a single location. The information was last updated on September 29th 2022."

Answered by AI

Does this research represent a pioneering exploration?

"Following the initial trial of 60 patients in 2002, sponsored by Schering-Plough, Radiation Therapy received its Phase 2 drug approval. Nowadays there are 206 active studies across 935 cities and 36 countries that research this therapy's efficacy."

Answered by AI

Recent research and studies

NeuroImage: ClinicalJournal

Characterization of Serial Hyperpolarized 13C Metabolic Imaging in Patients with Glioma

Autry, Adam W., Jeremy W. Gordon, Hsin-Yu Chen, Marisa LaFontaine, Robert Bok, Mark Van Criekinge, James B. Slater, et al.. 2020. “Characterization of Serial Hyperpolarized 13C Metabolic Imaging in Patients with Glioma”. Neuroimage: Clinical. Elsevier BV. doi:10.1016/j.nicl.2020.102323.

clinicaltrials.govStudy

Hyperpolarized Imaging in Diagnosing Participants With Glioma

Susan Chang 2015. "Hyperpolarized Imaging in Diagnosing Participants With Glioma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03739411.

All > Glioma